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Multiplex gene-panel testing for lung cancer patients.

Yasushi Yatabe1, Kuniko Sunami2, Koichi Goto3

  • 1Department of Diagnostic Pathology, National Cancer Center, Tokyo, Japan.

Pathology International
|September 21, 2020
PubMed
Summary

Japan

Keywords:
gene-panel testlung cancermolecular testingnext-generation sequencing

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Area of Science:

  • Oncology
  • Genomics
  • Molecular Diagnostics

Background:

  • 2019 marked the introduction of cancer genome medicine in Japan with three next-generation sequencing (NGS) gene-panel tests.
  • These tests detect genetic alterations in tumors, aiding therapeutic development and understanding molecular pathways.
  • Pathologists play a crucial role in ensuring adequate tissue size and tumor cell content for NGS testing.

Purpose of the Study:

  • To review Japan's current reimbursement policies for NGS cancer gene-panel testing.
  • To outline specimen requirements for NGS testing based on recent Japanese Society of Lung Cancer guidelines.

Main Methods:

  • Review of national healthcare reimbursement policies for molecular testing.
  • Analysis of the 'Guidance of Gene-panel Testing Using Next-Generation Sequencers for Lung Cancer' by the Japanese Society of Lung Cancer.
  • Comparison of the clinical application and accessibility of different NGS tests (Oncomine CDx Target, NCC OncoPanel, FoundationOne CDx).

Main Results:

  • One NGS test (Oncomine CDx Target) is approved for regular molecular testing in lung cancer for targeted therapy selection.
  • Two other NGS tests (NCC OncoPanel, FoundationOne CDx) are restricted to patients who have completed or will complete standard treatment.
  • These tests are implemented within the National Cancer Genome Medicine Network.

Conclusions:

  • The accessibility and application of NGS gene-panel tests in Japan differ based on their approval status and reimbursement.
  • Understanding specimen requirements and national guidelines is essential for effective implementation of NGS in lung cancer diagnostics.
  • Pathologist involvement is critical for successful NGS testing in clinical practice.